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Wednesday, June 20, 2012

In a battle against prescription drug abuse and diversion, primarily involving opioid pain relievers, the U.S. Drug Enforcement Agency (DEA) has launched attacks on wholesalers and pharmacies within the legitimate supply chain. Questions are being raised about the foresight of such tactics, as healthcare providers are becoming leery of prescribing and severe shortages of these vital analgesics loom over the horizon. In the end, patients with pain may become collateral damage in this “War on Rx-Drugs.”

According to a recent report from Reuters news service [“U.S. War on Drugs Moves to Pharmacy from Jungle”; June 16, 2012, here], in response to ever-increasing concerns about the diversion of prescription pain relievers to illegitimate use, the DEA has beefed up its efforts at deterrence and is deploying many of the tactics it uses to combat illegal drugs, such as wire taps, undercover operations, and informants.

Such efforts have helped it dismantle many “pill mills” — bogus pain clinics writing thousands of questionable prescriptions — as well as rogue Internet pharmacies. However, the agency is now applying the same tactics to prosecute the legitimate pharmaceutical supply chain, including wholesalers and pharmacies that must follow strict record-keeping and security rules to prevent drug diversion.

Tactical Maneuvering

During the past few years, according to the Reuters report, the DEA has stepped up its inspections and levied millions of dollars in fines against drug wholesalers for what it claimed were breaches of the rules. Last February, the DEA suspended the license of drug wholesaler Cardinal Health Inc. to sell opioid analgesics and other controlled substances from its center in Lakeland, Florida. The DEA said the wholesaler had failed to detect suspicious order volume from several of its pharmacy customers.

Under a settlement, Cardinal agreed not to ship controlled substances from that facility for 2 years. Then, shortly afterward, the DEA raided two CVS pharmacies and issued inspection warrants at a half-dozen Walgreens drugstores and a Walgreens distribution center.

DEA Administrator Michele Leonhart has defended the actions as essential for combating prescription drug abuse and diversion. But critics say that applying the same strong-arm tactics to the legitimate supply chain as to Colombian drug lords is ineffective and is also causing supply shortages that harm patients with pain.

“Going after a pharmaceutical [distributor] is not like going after the Medellin cartel,” said Adam Fein of Pembroke Consulting. “I don’t believe it is appropriate for the DEA to shrink the supply of prescription drugs, because it has unanticipated effects that have nothing to do with the problem.”

However, the DEA has come under increasing pressure from Congress to show it is containing the diversion problem. Leonhart claims that the best benchmarks of the agency’s success should be the disruption and destruction of the organizations and the networks feeding the problems, so the agency is going in that direction. The DEA has expanded its use of tactical squads, combining special agents, diversion investigators, and local law enforcement officers to track down and prosecute prescription drug dealers.

Still, the Reuters report observes, “sending in tactical diversion squads to break up pill mills does not address the leaks occurring from medicine cabinets at home or the drugs passed along from friends and family. That is one reason the DEA is attempting to squeeze supplies at the wholesale level.”

John Coleman, a former DEA chief of operations, comments that “Going after Cardinal has sent shivers up the distributor grapevine.” Along with that, “close a CVS pharmacy in Florida, and I guarantee every pharmacy within 500 miles will be checking their records,” he says.

Fears Running Rampant

Pharmacists confirm that they are indeed fearful, Reuters reports, with some being reluctant to accept new customers requiring prescription analgesics. Others will only accept patients within a certain geographic area or refuse to accept cash.

“We turn away five or six people a day,” said Steven Nelson, owner of a discount drugstore in Okeechobee, Florida, and chairman of governmental affairs for the Florida Pharmacy Association. Even large chains are leery:

Walgreens spokesman Michael Polzin said that after looking into everything going on in Florida, “we’ve decided not to comment on our operations there at this time.”

CVS pharmacies across Florida stopped filling prescriptions written by 22 of the top-prescribing physicians, pending a review of their dispensing practices. The company declined to elaborate on its actions, except to say that it will continue to monitor prescriptions for controlled substances and is “committed to supporting efforts to prevent drug abuse and keep controlled substances out of the wrong hands.”

Physicians are equally fearful, according to Reuters. Many have increased patient monitoring, which means more urine tests, more documentation, and more frequent “pill count” checks, where patients must go to the prescriber’s office with their pill bottles to prove they have not sold or misused their medication.

“Every hour of the day I have concerns I’ll be audited, that my ability to take care of my patients and my family can be taken away, and I’m as legitimate as you can get,” said one prescriber who has a private orthopedic practice in Florida. “You’re constantly watching over your shoulder and it takes a toll,” he told Reuters news.

Slashing Supplies, Raising Questions

During the past 5 years, Cardinal has cut supplies of controlled substances to more than 375 customers nationwide, including 180 pharmacies in Florida, Reuters reports. Other wholesalers are similarly cautious; AmerisourceBergen Corp. now monitors orders for suspicious increases of 20% to 30% in volume.

All of those involved — wholesalers, pharmacists, prescribers — claim they want to help curtail abuse, but DEA rules have not always been clear. Meanwhile, the DEA’s Leonhart rejects that notion, claiming the agency has repeatedly communicated its requirements in meetings and presentations.

But John Burke, president of the nonprofit National Association of Drug Diversion Investigators (NADDI), says the DEA behaves as though those it monitors are the enemy. “The mindset is, these are folks we have to keep at arm’s length,” he told Reuters.

The DEA’s strategy is also prompting new questions from Congress. Reuters reports that Senators Chuck Grassley of Iowa and Sheldon Whitehouse of Rhode Island asked the GAO (Government Accountability Office) to study whether the agency’s actions are contributing to shortages of medications for pain patients.

Others say the DEA should not be in the business of regulating industry at all. Scott Gottlieb, former deputy commissioner of the Food and Drug Administration (FDA), publicly criticized the DEA for attacking prescription drug problems in the same way it pursues criminal drug cartels. “The problem is, the DEA may be the wrong enforcer here. It’s very difficult to separate appropriate use from illicit use with law-enforcement tools alone,” Gottlieb wrote in the Wall Street Journal [“The DEA’s War on Pharmacies—and Pain Patients”; March 22, 2012; here].

The DEA’s confrontation with wholesalers and pharmacies follows public concerns about who has been responsible for shortages of many critical drugs within the healthcare system nationwide. The Reuters report notes that the DEA strictly controls the amount of an ingredient in a potentially addictive drug that its manufacturer can obtain each year, based on the projected needs of legitimate patients. Manufacturers have claimed that the agency does not always authorize enough material in time for them to amply supply customers with products. The DEA counters that shortages are resulting from unspecified poor business decisions made by the companies.

Meanwhile, the Reuters report observes, patients with pain, unable to access a needed supply of prescribed analgesics, are struggling to function. Substitute pain medications often are inadequate and even those are becoming scarce.

COMMENTARY: An Unintended Public Health Crisis

The above article adapted from Reuters news pretty much tells the tale of how the war on illicit drugs in America has shifted to a war on prescription pain-relievers, namely opioid analgesics, in which patients with chronic pain are becoming collateral damage. What has happened in Florida may be only a harbinger of what is to come around the country, and in other countries.

The aggressive tactics being initiated by government regulatory and law enforcement agencies against legitimate operations within the pharmaceutical supply chain — wholesalers, pharmacies, prescribers — seem unprecedented in American history. One can hardly blame these businesses and healthcare providers for their fears, motivating them to drastically curtail product prescribing, dispensing, and distribution rather than risk being shut down entirely. Perhaps, this is exactly what the government intended to happen.

Clearly, the bellwether victims in this “war” are patients with chronic pain whose ongoing access to essential pain-relievers has disintegrated or is increasingly threatened. Next, however, there could be supply shortages of vital opioid analgesics even for treating acute pain conditions — a broken bone, surgical wound, and the like — or severe cancer-related pain; an unimaginable but looming possibility.

Decision-makers and leaders at all levels of government owe it to the public to consider the long-term consequences of actions today that could incur extensive and unnecessary suffering tomorrow. There is no doubt that problems of Rx-drug misuse, abuse, overdose, and diversion are real, of considerable magnitude, and of great significance. However, the government’s shortsighted efforts to quickly stem those problems may end up causing an enduring public health crisis of extraordinary proportions.

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